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NIAID Division of Microbiology and Infectious Diseases (DMID) Metadata Implementation Guidelines

For Transfer of Metadata Associated with Genomic Sequencing Projects

In consultation with the primary investigators and staff of the Genomic Sequencing Centers for Infectious Diseases (GSCs), the Bioinformatics Resource Centers (BRCs), the GSC collaborators, and an external Working Group consisting of scientists with expertise in clinical research data management and infectious diseases, NIAID/DMID has established the following implementation guidelines for transfer of metadata associated with genomic sequencing projects.

  1. Genomic Sequencing Centers for Infectious Diseases (GSC) Collaborators
      a. GSC collaborators must submit a white paper to NIAID. If approved, GSCs discuss with collaborators the NIAID/DMID Data Sharing and Release Guidelines and issues related to sharing clinical metadata including the rights and privacy of human subjects which must be protected at all times in compliance with HIPAA.

      b. GSC collaborators ensure that proper patient consents and Institutional Review Board (IRB) approvals for all the samples are in place before submitting any clinical data to the public databases.

      c. GSCs will provide to collaborators the standardized metadata templates along with other templates for capturing project-specific and clinical information. Collaborators should be encouraged to submit other metadata fields not listed on the template, including clinical data fields, to GSCs as additional fields on the metadata template. GSC collaborators shall contact the GSCs on issues related to the use of the templates and data submission.

      d. GSC collaborators fill out the templates and send them back to the GSCs. The institutions of the GSC collaborators will have primary responsibility for ensuring that the submitted data are de-identified, compliant with HIPAA and compliant with the NIAID/DMID Data Sharing and Release Guidelines. Collaborators will be encouraged to provide suggestions to the GSCs for possible improvements and modifications to the templates; GSCs will provide these ideas to the GSC-BRC metadata working groups for further evolution of the metadata templates.
  2. Genomic Sequencing Centers for Infectious Diseases (GSCs)
      a. Upon receipt of the metadata from the GSC Collaborator, GSCs will review the metadata fields and datasets submitted from the collaborators to ensure that the data are de-identified, and are compliant with HIPAA and the NIAID/DMID Data Sharing and Release Guidelines. GSCs submit the de-identified metadata package with the Organization and Management plan for review and approval by NIAID.

      b. Per the Guidelines, after approval by NIAID, GSCs will make the complete metadata set from a sequencing project available to the BRCs at the time that the genomic data are submitted to NCBI. If the sequencing for a project is conducted in a batch fashion, the metadata package shall be made available to BRCs when or before any genomic data are submitted to NCBI. GSCs shall make available to BRCs information that links metadata to the genomic data deposited in GenBank as soon as such information is available.

      c. GSCs inform NIAID about the transfer of the metadata and other relevant information to the BRCs.
  3. Bioinformatics Resource Centers (BRCs)
      a. BRCs inform NIAID upon the receipt of new metadata information from the GSCs.
      b. BRCs conduct quality assurance on the metadata received, including checking for compliance with HIPAA and the NIAID/DMID Data Sharing and Release Guidelines.

      c. BRCs upload metadata into the BRC databases, and ensure the metadata are linked to the relevant genomic data downloaded from GenBank. BRCs release data through the BRC web sites.

Last Updated June 05, 2013